BACKGROUND: There is no clinical evidence supporting medical treatment for the failing
systemic right ventricle in patients with transposition of the great vessels with atrial
switch. Cardiac magnetic resonance studies have shown a significant degree of myocardial
fibrosis in right ventricles in the systemic position, which predisposes to systolic and
diastolic dysfunction. Aldosterone is a widely recognized neurohormonal marker involved in
the formation of myocardial fibrosis and the treatment with aldosterone antagonists has shown
a decrease in ventricular mass in hypertensive patients, presumably related to reduction of
myocardial fibrosis.
HYPOTHESIS: Low dose of eplerenone, a selective mineralocorticoid receptor blocker, in
patients with systemic right ventricle can reduce the ventricular mass by means of a
reduction in myocardial fibrosis, resulting in improved systolic function.
PATIENTS AND METHODS: Randomized, double blind, parallel clinical trial comparing eplerenone
(50mg daily) with placebo.
Study population: Adult patients (>18 years) diagnosed with repaired transposition of the
great arteries with atrial switch (Senning or Mustard techniques) routinely followed at a
tertiary referral center.
Duration: 12 months. Outcomes: Right ventricular mass, myocardial fibrosis mass and ejection
fraction assessed by cardiac magnetic resonance.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute